JP3871070B2 - Intravascular occlusion device - Google Patents

Intravascular occlusion device Download PDF

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Publication number
JP3871070B2
JP3871070B2 JP26827595A JP26827595A JP3871070B2 JP 3871070 B2 JP3871070 B2 JP 3871070B2 JP 26827595 A JP26827595 A JP 26827595A JP 26827595 A JP26827595 A JP 26827595A JP 3871070 B2 JP3871070 B2 JP 3871070B2
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Prior art keywords
conductive coil
removable conductive
coil
removable
occlusion
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Expired - Fee Related
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JPH08196544A (en
Inventor
ガグリエルミ ガイド
ジ チェン
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ザ リージェンツ オブ ザ ユニバーシティ オブ カリフォルニア
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Priority to US08/323,662 priority patent/US5569245A/en
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/082Probes or electrodes therefor
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    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
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    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
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Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to the field of coagulation of tissues such as blood by electrical action, and more particularly to the use of alternating current to form an intravascular occlusion.
[0002]
[Prior art]
Occlusion of the tubule structure with an intravascular catheter has recently been realized by the use of a removable balloon, an injectable coagulant, a removable or insertable coil, and injectable particles. Removable balloons have the property that they are practically used only in large tubes. Injectable coagulants are limited in their use because of the difficulty in controlling delivery to the desired occlusion site. Removable and insertable coils are effective, but in some cases do not form thrombus sufficiently. The use of injectable particles has the disadvantage that it is difficult to control the relative invisibility in fluoroscopy and the final placement at the desired occlusion site. In many prior arts, the coagulation wire must be removed by severing the coagulum, which usually results in severe failure, or even the occlusion must be reopened.
[0003]
The use of both alternating and direct currents to form coagulation by electrical action is well known and reference is made to the literature listed below.
[0004]
However, each of these experimental studies is generally done in large tubes and has not established controllability and effectiveness for use in smaller tubes.
[0005]
[Non-Patent Document 1]
Gold et al., "Transarterial Electrocoagulation Therapy of a Pseudoaneurysm in the Head of the Pancreas", American Journal of Roentgenology, Volume 125, No. 2, at 422 (1975)
[Non-Patent Document 2]
Thompson et al., `` Vessel Occlusion with Transcatheter Electrocoaguftion: Initial Clinical Experience '', Diagnostic Radiology at 335 (November 1979)
[Non-Patent Document 3]
Thompson et al., `` Transcatheter Electrocoagulation: A Therapeutic Angiographic Technique for Vessel Occlusion '', Investigative Radiology at 146 (March-April 1977)
[Non-Patent Document 4]
Phillips et al., "Transcatheter Electrocoagulation of Blood Vessels", lnvestigative Radiology at 295 (September-0ctober 1973)
[Non-Patent Document 5]
Phillips et al., `` Experimental Closure of Ateriovenous Fistula by Transcatheter Electrocoagulation '', Diagnostic Radiology 115: 319 (May 1975)
[0006]
[Problems to be solved by the invention]
Thus, it is controllable in terms of being visible, biocompatible, and optionally removable at the desired site, such as the end of a delivery microcatheter, and is capable of directional control, blood and tubing What is needed is a clinical occlusion device that is effective in coagulation of the body and can be used in small tubes without the risk of breaking or reopening the occlusion at the end of the procedure.
[0007]
[Means for Solving the Problems]
The present invention is an apparatus for selectively providing intravascular occlusion within a patient's body. The apparatus includes a transport wire that can be guided to or near the intravascular closure site. A removable conductive coil is temporarily and selectively coupled to the carrier wire. An alternating current generator is coupled to a selectively removable conductive coil to provide current to the coil to coagulate tissue such as blood by electrical action. As a result, a controllable occlusion device is provided that is effective and usable in small tubes.
[0008]
The apparatus further comprises a direct current generator that is selectively coupled to a removable conductive coil. A switch selectively couples to an AC current generator and / or DC current generator that is removable. In the preferred embodiment, the coil is a GDC coil. The current values of the AC and DC current generators can be variably controlled, and the frequency of the AC current generator can be controlled variably.
[0009]
The apparatus further comprises a sensing circuit for determining when a coagulation state of tissue such as blood has been achieved by a predetermined electrical action at or near the removable conductive coil. The sensing circuit senses the impedance of the removable coil inside the patient. The apparatus further includes a control circuit that selectively initiates coil removal when the sensing circuit determines that a coagulation state due to a predetermined electrical action has been achieved.
[0010]
The alternating current generator heats the removable conductive coil and surrounding blood tissue by its electrical resistance and / or dielectrically heats the removable conductive coil and surrounding blood tissue at radio frequency.
[0011]
The present invention is also an apparatus for forming an intravascular occlusion at a selective occlusion site, the apparatus comprising a conductive carrier wire, coupled to the carrier wire and disposed by the carrier wire at or near the occlusion site. It has a conductive coil that can be selectively placed and removed. An alternating current signal source is electrically coupled to the carrier wire and the coil to provide a heating energy source for the coil. As a result, the device is a controllable occlusion device that is effective and usable in small tubes.
[0012]
The removable conductive coil can be removed electrolytically or mechanically removed. The apparatus further includes a control circuit that determines when coagulation by a predetermined electrical action has occurred in the coil and removes the coil from the carrier wire. When a DC current signal source is electrically coupled to a removable conductive coil and coagulation occurs due to a predetermined electrical action, the control circuit turns off the AC current signal source and turns on the DC current signal source. Remove the coil from the carrier wire.
[0013]
The present invention is also a method of forming a tube occlusion, the method providing a conductive carrier wire and placing a conductive coil coupled to the carrier wire at or near a selected occlusion site Including that. An alternating current is applied to the coil and solidification occurs at the occlusion site. A determination is made whether coagulation due to a predetermined amount of electrical action has occurred at the occlusion site. If the determining step determines that solidification has occurred due to a predetermined electrical action, the alternating current of the coil is terminated. The coil is then removed from the carrier wire and left at the occlusion site. As a result, occlusion is effectively effected in a small tube.
[0014]
In the preferred embodiment, the removal of the coil from the carrier wire is automatic and the coil is electrolytically separated from the carrier wire.
[0015]
The present invention is more visually represented by reference to the accompanying drawings. In the drawings, similar elements are referred to by similar numbers.
[0016]
The invention and its many embodiments will be better understood by reference to the following detailed description.
[0017]
DETAILED DESCRIPTION OF THE INVENTION
A device is provided for electrically coagulating blood and tissue at the occlusion site by means of applying an alternating signal or alternating current through a removable conductive coil on the end of the delivery wire. Preferably, Gug1ie1mi Detachable Coil (GDC) is used with radio frequency energy to provide local heating in the coil. When blood carbonization occurs in the removed region of the GDC coil, the overall system impedance increases. An increase in impedance is detected and the alternating current is automatically turned off, then a direct current is applied and the GDC coil is electrolytically removed from the carrier wire.
[0018]
The device of the present invention uses a removable microcatheter coil system and AC and DC current sources. The electrolytically removable coil system has been commercialized by the Target Therapeutics of Ca1ifornia as the Gug1ielmi Detachab1e Coi1 System (hereinafter referred to as the GDC coil or system), which has a mechanically or electrolytically removable end. A direct current source coupled to the wire guided by the microcatheter is provided with the partial coil. Any of the embodiments described in US Pat. No. 5,122,136, 5226911, and / or US Pat. No. 5,354,295 can be used in the apparatus of the present invention. US Pat. Nos. 5,122,136, 5226911, and 5354295 are all incorporated herein by reference. Mechanical means for removing the coil from the catheter are described in US Pat. Nos. 5,234,437 and 5,261,916, which are also incorporated herein by reference.
[0019]
FIG. 1 is a very schematic view of a device used to create an intravascular occlusion. The GDC system 10 incorporates a guideable microcatheter 12, which in the illustrated embodiment is a tracker intravascular catheter manufactured by Target Therapeutics, Inc. of Fremont, California. The GDC coil 14 is placed at or near the selected occlusion site 16, which is usually in a small tube. The GDC coil 14 is generally manufactured from platinum and can be of any physical shape, form, or composition as described or known in the aforementioned referenced patents. For example, the GDC coil 14 can be formed into a preferred shape, linearly, curvilinearly, radially, with a biasing force applied to the spiral, otherwise it is completely flexible. Is possible. The GDC coil 14 can also incorporate fibers or other equivalent micro-occlusive structures. The device of FIG. 1 is particularly convenient for arterial occlusions such as arteriovenous malformations, arteriovenous fistulas, and ductal tumors.
[0020]
For example, in the embodiment of FIG. 2, the microcatheter 12 is shown to carry a coated guidewire 18 extending from the catheter tip 20.
[0021]
In place, the coated guidewire is stripped and given a bare wire 22 that is connected to the GDC coil 14 at a connection point 24.
[0022]
The GDC coil 14 is disposed at or near the site 16, and an AC signal generator 26 is connected to the vicinity of the end of the carrier wire 22 via the switching circuit 28. As in the prior art, coagulation by the desired electrical action is performed on blood and human body tissue in contact with or near the portion where the coating of the GDC coil 14 and the wire 22 at the end of the microcatheter 12 is peeled off. An alternating current is applied at a frequency, voltage, current repetition time, waveform, and other signal characteristics that can be induced. The region in contact with or near the coated portion 18 of the carrier wire 22 does not solidify due to electrical action.
[0023]
A ground wire 30 is provided to the patient by the conductive skin adhesive pad. This is shown schematically as a symbol in FIG. An alternating signal or alternating current applied through the GDC coil 14 induces heating in the uncoated platinum portion of the GDC coil and / or in the vicinity of the artery or vessel wall surrounding the GDC coil 14 and tissue such as blood. To do. The coated portion of the carrier wire must extend from the shoulder joint 24 supporting the coil 14 to approximately 0.5 mm, so that it is substantially removable when an alternating current or RF is applied. A clot is formed only around 14 and no clot is formed around the transport wire. The frequencies used in the device of the present invention include from very low frequencies just above the direct current to radio frequencies, and its spectrum extends from below 1 hertz to several gigahertz. The frequency can be selected to match a radio frequency absorption peak for any component at the occlusion site 16, such as water. Tubular structures or blood proteins are altered by heating, resulting in contraction of the tube wall and / or blood clots. For example, it is known that collagen fibers in the tube wall are contracted at a temperature of 60 ° C. or higher.
[0024]
The power provided by the AC signal generator 26 is variable by the operator via the interface unit 36, and the interface unit 36 is coupled to the generator 26 either directly or via the switching circuit 28. The variability of the output of the alternating current generator 26 via the power, voltage, current, and repetition rate interface 32 performs tube occlusion without damaging the tube wall, minimizing undesired heating of the surrounding tissue. Used to limit or substantially avoid. The AC signal generator 26 is a variable AC current generator having a voltage in the range of 0 to 70V and is preferably battery powered by a rechargeable battery. The waveform is selectable via the interface 32 and can be a customized waveform, typically having a sine wave, square wave, triangular wave, or variable frequency pulse rate.
[0025]
The alternating current signal waveform is continuously monitored via the interface 32 and tube occlusion is immediately detected by a change in waveform due to blood carbonization on the removal region near the connection point 24 on the GDC coil 14. . This waveform change due to blood carbonization is determined by the impedance change of the system shown in FIG. Accordingly, the interface 32 is intended to include an impedance detector that automatically generates an audible signal to the operator or triggers the alternating current generator 26 to be automatically turned off. When it is determined that sufficient coagulation has occurred, the direct current generated by the direct current generator 34 and coupled to the carrier wire 22 via the switching circuit 28 causes the GDC coil 14 to be as described in the aforementioned referenced patent. Is removed. The switching circuit 28 can be manually driven by an operator or can be automatically programmed so that a suitable direct current for separation upon completion of coagulation by electrical action due to an alternating current. Is switched to send
[0026]
The GDC coil 14 is particularly effective in the apparatus of FIG. In contrast to other types of intraductal coils, the GDC coil 14 can be removed from the delivery catheter 12 and from its distal end after tube occlusion is achieved. Various sizes, various shapes and configurations with diameters ranging from 0.13 to 5.1 mm (0.005 to 0.2 inches), and diameters from 0.025 to 0.102 mm (0.001 to 0.001). A flexible coil using platinum wire in the range of 004 inches or more can be used as the desired coil as coil 14. Platinum wires with different electrical resistances can be used.
[0027]
Although the embodiment of FIG. 1 is shown as having an alternating current generator 26 and a direct current generator 34 as separate units, both units and the interface 32 with the impedance detection circuit described above may be combined in a single circuit. It can be incorporated into. The impedance detection subcircuit turns off the alternating current signal, drives the direct current signal, and removes the GDC coil 14. In this embodiment, after setting the initial parameters, the operator cycles through the entire process by simply turning on a single drive switch. Acoustic or audiovisual feedback can be provided to display both AC tube blockage and GDC coil 14 removal. For example, both the direct current and alternating current components of the signal can be generated digitally via an interface controlled by personal computer software. The power level is low, typically in the range of 0.1 to 20 watts, and a broadband generator can be used. Alternatively, the interface 32 can be used to selectively couple two or more individual generators to the catheter 12 to completely cover the desired frequency band described above.
[0028]
Conventional guidewires 22 are sufficient for transmission from direct current to megamerz signals, but it is possible that power loss may be unacceptable for higher frequencies in the gigahertz band. Thus, in such cases, the guidewire 22 is alternatively known or later developed suitable to carry flexible microcoaxial cables, microwave transmission striplines or power levels and frequencies described herein. It can be manufactured in the form of other transmission means. Many variations and modifications can be made by those skilled in the art without departing from the spirit and scope of the invention. Accordingly, it is to be understood that the disclosed embodiments are set forth by way of illustration only and are not intended as limitations on the invention as defined by the claims.
[0029]
The terms used in the text describing the present invention and many embodiments of the present invention exceed the meanings generally defined by a particular definition, not just their generally defined meanings. It is a combination of structure, material or action. Accordingly, the definition of a term or element in a claim means not only a combination of elements in a word meaning but also substantially the same action in substantially the same way to obtain substantially the same result. It is defined in this specification to include all equivalent structures, materials or acts. In addition to the equivalents of the elements recited in the claims, any known or later known substitution obvious to those skilled in the art is defined as being within the scope of the elements of the invention.
[0030]
Accordingly, the claims are intended to essentially incorporate the essential details of the invention, as specifically illustrated and described above, as conceptually equivalent thereto, as obvious substitutes, and as such. It should be understood to include matters.
[0031]
【The invention's effect】
As described above, the present invention is controllable and directional control in that it is visible, biocompatible, and can be optionally removed at a desired site, such as the end of a delivery microcatheter. Provides a clinical occlusion device that can be used in small vessels without risk of breaking or reopening the occlusion at the end of the procedure Is done.
[Brief description of the drawings]
FIG. 1 is an idealized diagram of the device of the present invention.
FIG. 2 is an enlarged view of one embodiment of a catheter used with the apparatus of FIG.
[Explanation of symbols]
10 ... GDC system, 12 ... microcatheter, 14 ... GDC coil.

Claims (13)

  1. A device that selectively provides intravascular occlusion in a patient's body,
    A conveyance wire that can be guided to or near the occlusion site in the tube;
    A removable conductive coil that is temporarily and selectively coupled to the transport wire and is transported and disposed by the transport wire to the closure site;
    An alternating current selectively coupled to the removable conductive coil and capable of selecting a frequency to match a radio frequency absorption peak at the occlusion site is provided to the removable conductive coil to provide the removable conductive coil. An alternating current generator that forms a blockage in the blood in the vicinity of the removable conductive coil by dielectrically heating the sex coil and surrounding blood tissue at a radio frequency;
    A direct current generator selectively coupled to the removable conductive coil to supply a direct current to the removable conductive coil to electrolytically remove the removable conductive coil;
    A switch for selectively coupling the AC current generator and the DC current generator to the removable conductive coil, wherein the AC current is supplied to the removable conductive coil to be removed. A switch that automatically switches to deliver the direct current to the removable conductive coil after an intravascular occlusion is formed in the blood in the vicinity of
    It provides a controllable occlusion device that is effective and usable within a small tube,
    Intravascular occlusion device.
  2. The apparatus of claim 1, wherein the removable conductive coil is a GDC coil.
  3. The apparatus according to claim 1, wherein the alternating current generator is variably controllable.
  4. The apparatus according to claim 1, wherein the direct current generator is variably controllable.
  5. The apparatus of claim 1, wherein the AC and DC current generators are variably controllable.
  6. The apparatus according to claim 3, wherein the controllable AC current generator is capable of variable frequency control.
  7. A device that selectively provides intravascular occlusion in a patient's body,
    A conveyance wire that can be guided to or near the occlusion site in the tube;
    A removable conductive coil that is temporarily and selectively coupled to the transport wire and is transported and disposed by the transport wire to the closure site;
    An alternating current selectively coupled to the removable conductive coil and capable of selecting a frequency to match a radio frequency absorption peak at the occlusion site is provided to the removable conductive coil to provide the removable conductive coil. An alternating current generator that forms a blockage in the blood in the vicinity of the removable conductive coil by dielectrically heating the sex coil and surrounding blood tissue at a radio frequency;
    A direct current generator selectively coupled to the removable conductive coil to supply a direct current to the removable conductive coil to electrolytically remove the removable conductive coil;
    A sensing circuit for determining when a predetermined coagulation state is achieved by electrical action at or near the removable conductive coil ;
    Ri Na and a switch for selectively coupling the alternating current generator and the DC current generator to said removable conductive coil,
    It provides a controllable occlusion device that is effective and usable within a small tube,
    Intravascular occlusion device.
  8. The apparatus of claim 7, wherein the sensing circuit senses an impedance of the removable conductive coil in the patient.
  9. 8. The apparatus of claim 7, further comprising a control circuit that selectively initiates removal of the removable conductive coil when the sensing circuit determines that the coagulation state due to electrical action has been achieved.
  10. The apparatus of claim 1, wherein the alternating current generator heats the removable conductive coil and surrounding blood tissue by the electrical resistance of the removable conductive coil.
  11. A device for forming an intravascular occlusion at a selective occlusion site,
    A conductive carrier wire;
    A conductive coil coupled to the carrier wire, and selectively displaceable and removable that can be placed by the carrier wire at or near the closure site;
    A radio frequency alternating current signal source electrically coupled to the carrier wire and the removable conductive coil to provide a source of heating energy in the removable conductive coil;
    A direct current signal source electrically coupled to the carrier wire and the removable conductive coil to provide a direct current for electrolytically removing the removable conductive coil ;
    A control circuit for determining when a predetermined coagulation by electrical action has occurred at the location of the removable conductive coil and then removing the removable conductive coil from the carrier wire ;
    Thereby, the device is available in a small tube and becomes an effective controllable occlusion device,
    Intravascular occlusion device.
  12. The apparatus of claim 11, wherein the removable conductive coil is a GDC coil.
  13. The control circuit turns off the alternating current signal source when the predetermined coagulation due to the electrical action occurs, turns on the direct current signal source, and removes the removable conductive coil from the carrier wire. The apparatus of claim 11 .
JP26827595A 1990-03-13 1995-10-17 Intravascular occlusion device Expired - Fee Related JP3871070B2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US323662 1994-10-17
US08/323,662 US5569245A (en) 1990-03-13 1994-10-17 Detachable endovascular occlusion device activated by alternating electric current

Publications (2)

Publication Number Publication Date
JPH08196544A JPH08196544A (en) 1996-08-06
JP3871070B2 true JP3871070B2 (en) 2007-01-24

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JP26827595A Expired - Fee Related JP3871070B2 (en) 1990-03-13 1995-10-17 Intravascular occlusion device

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US (1) US5569245A (en)
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JP (1) JP3871070B2 (en)
AT (1) AT199307T (en)
AU (1) AU704583B2 (en)
CA (1) CA2160640A1 (en)
DE (2) DE69520186D1 (en)
IL (1) IL115609A (en)
TW (1) TW340793B (en)

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CA2160640A1 (en) 1996-04-18
DE69520186T2 (en) 2001-06-21
US5569245A (en) 1996-10-29
AU704583B2 (en) 1999-04-29
EP0707830A1 (en) 1996-04-24
AU3429195A (en) 1996-05-02
AT199307T (en) 2001-03-15
TW340793B (en) 1998-09-21
IL115609D0 (en) 1996-01-19
IL115609A (en) 1999-07-14
JPH08196544A (en) 1996-08-06
DE69520186D1 (en) 2001-04-05
EP0707830B1 (en) 2001-02-28

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